Lupin has received tentative approval from the US Food and Drug Administration (USFDA) for its New Drug Application for Apixaban Oral Suspension 1.25 mg/mL. 

The regulatory development strengthens the company’s portfolio of differentiated medicines in the US market and could open another opportunity in the anticoagulation segment.

The product has been developed through the 505(b)(2) regulatory pathway and is an oral liquid formulation of apixaban, the active ingredient in Bristol Myers Squibb’s Eliquis. It is designed as an alternative administration option for adults who require anticoagulation therapy, including patients who may have difficulty swallowing tablets.

Unlike a standard tablet formulation, the oral suspension could offer greater flexibility for certain patients who face challenges with conventional dosage forms. The product therefore adds a differentiated formulation to Lupin’s US portfolio rather than being another standard generic tablet.

Lupin said the product will be manufactured at its Somerset, New Jersey facility once it receives final approval. The company expects its US-based manufacturing capabilities to support supply reliability and quality standards for the formulation.

The latest approval is part of a broader series of regulatory developments for Lupin in the US. The company received USFDA approval for Modafinil Tablets in September and Pitolisant Tablets in August. It also received approval for Sodium Zirconium Cyclosilicate for Oral Suspension in August, highlighting the continued expansion of its US product pipeline.

Lupin has been focusing on complex generics, specialty medicines and differentiated formulations as it looks to strengthen its presence in key international markets. The company has a significant US business, making new product approvals an important part of its growth strategy.

However, the latest development is only a tentative approval, meaning commercialisation of the Apixaban oral suspension remains subject to final regulatory clearance and applicable requirements. The actual financial contribution will depend on the final approval, launch timing and market conditions.

The development adds another potential product to Lupin’s US portfolio while reinforcing its focus on complex and patient-friendly drug formulations.

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